A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma
Status:
Recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery
followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain
tumors which causes damage to the tumor cells. However, radiotherapy can also affect the
surrounding healthy cells in the brain, causing inflammation and swelling in the region,
which is known as radio necrosis (RN). This is considered a late side effect of radiation and
is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes,
radionecrosis can be detected on routine imaging during follow-up without new symptoms
(asymptomaticRN).
At the same time, in some patients, it can give rise to new symptoms like headaches,
weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid
medicines called dexamethasone, which is helpful in a proportion of patients.
This is a prospective phase 2 study. This study is being conducted to investigate the ability
of the drug Chlorophyllin in the treatment of radionecrosis.
Chlorophyllin is a water-soluble compound obtained from the green plant pigment called
chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral,
anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is
an over-the-counter drug in various countries, and also as a food colouring agent.
This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our
primary aim of the study is to assess whether CHL will improve the clinical-radiological
response rates. This study will be conducted on a population of 118 patients for a duration
of 3 months. The total study duration is 2 years.
The study is funded by Bhabha Atomic Research Centre (BARC).